01 1Spectrum Pharmaceuticals
01 1APAZIQUONE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29743
Submission : 2015-11-30
Status : Inactive
Type : II
A Apaziquone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apaziquone, including repackagers and relabelers. The FDA regulates Apaziquone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apaziquone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Apaziquone supplier is an individual or a company that provides Apaziquone active pharmaceutical ingredient (API) or Apaziquone finished formulations upon request. The Apaziquone suppliers may include Apaziquone API manufacturers, exporters, distributors and traders.
click here to find a list of Apaziquone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Apaziquone DMF (Drug Master File) is a document detailing the whole manufacturing process of Apaziquone active pharmaceutical ingredient (API) in detail. Different forms of Apaziquone DMFs exist exist since differing nations have different regulations, such as Apaziquone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apaziquone DMF submitted to regulatory agencies in the US is known as a USDMF. Apaziquone USDMF includes data on Apaziquone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apaziquone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Apaziquone suppliers with USDMF on PharmaCompass.
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